search
Back to results

Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Simvastatin 80mg
Simvastatin 10mg
Sponsored by
Brasilia Heart Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Statin, Myocardial infarction, Insulin sensitivity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Less than 24 hours after the onset of MI symptoms
  • ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads
  • Myocardial necrosis, as evidenced by increased Creatine Kinase-MB (CK-MB) and troponin levels

Exclusion Criteria:

  • Diabetes or prior use of statins in the last 6 months

Sites / Locations

  • Hospital de Base do Distrito Federal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simvastatin 80mg

Simvastatin 10mg

Arm Description

Simvastatin 80mg once a day

Simvastatin 10mg once a day

Outcomes

Primary Outcome Measures

Insulin sensitivity
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp

Secondary Outcome Measures

Activation of insulin receptor substrate (IRS-1) and Akt protein
Verify the degree of phosphorylation of insulin receptor substrate (IRS-1) and Akt protein estimated by Western Blotting of the abdominal adipose tissue obtained by biopsy

Full Information

First Posted
September 17, 2010
Last Updated
September 8, 2013
Sponsor
Brasilia Heart Study Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01205347
Brief Title
Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
Official Title
Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brasilia Heart Study Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and long term. Recent studies, however, revealed that chronic statin treatment may decrease both insulin sensitivity and secretion immediately after statin therapy initiation. This study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.
Detailed Description
Stress hyperglycemia during myocardial infarction (MI) is a predictor of worse prognosis at short and long term. From the mechanistic standpoint, hyperglycemia can attenuate thrombolysis, increase platelet aggregation, induce coronary vasoconstriction, reduce oxygen transport and prolong endothelial inflammation after MI. Consistently, observational data indicates that glucose normalization improves survival in hyperglycemic patients hospitalized with MI. High dose potent statins have been included in the early treatment of acute coronary syndromes (ACS) based upon a broad range of potentially beneficial mechanisms. Recent studies, however, revealed that chronic statin treatment may increase the incidence of type 2 diabetes mellitus in a dose-dependent manner. Moreover, according to studies in cellular and animal models, such decrease in insulin sensitivity may be observed immediately after statin therapy initiation. By inference, one may speculate that statin treatment initiated at the acute phase of MI may potentially favor the appearance or aggravation of stress hyperglycemia. To date, however, this hypothesis has not been investigated. Hence, this study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Statin, Myocardial infarction, Insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin 80mg
Arm Type
Experimental
Arm Description
Simvastatin 80mg once a day
Arm Title
Simvastatin 10mg
Arm Type
Active Comparator
Arm Description
Simvastatin 10mg once a day
Intervention Type
Drug
Intervention Name(s)
Simvastatin 80mg
Other Intervention Name(s)
Zocor
Intervention Description
Simvastatin 80mg once a day
Intervention Type
Drug
Intervention Name(s)
Simvastatin 10mg
Other Intervention Name(s)
Zocor
Intervention Description
Simvastatin 10mg once a day
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Activation of insulin receptor substrate (IRS-1) and Akt protein
Description
Verify the degree of phosphorylation of insulin receptor substrate (IRS-1) and Akt protein estimated by Western Blotting of the abdominal adipose tissue obtained by biopsy
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Less than 24 hours after the onset of MI symptoms ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads Myocardial necrosis, as evidenced by increased Creatine Kinase-MB (CK-MB) and troponin levels Exclusion Criteria: Diabetes or prior use of statins in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei C Sposito, MD PhD
Organizational Affiliation
Faculty of Medical Sciences, State University of Campinas
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Base do Distrito Federal
City
Brasilia
State/Province
DF
ZIP/Postal Code
70000.000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

We'll reach out to this number within 24 hrs